A proof-of-concept evaluation of a perioperative, modular and audiovisual pelvic floor training for patients with a histologically confirmed prostate carcinoma as part of a robot-assisted, laparoscopic or open surgical radical prostatectomy.

Phase 1

Recruiting

• Conditions: C61; N39.3; Malignant neoplasm of prostate; Stress incontinence

• Registration Number: DRKS00025467
• Lead Sponsor: AKH ViersenKlinik für Urologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Only the following patients will be included in the observational study:
- all patients who consent to data collection
- all patients who have signed the informed consent form
- all patients who are legally competent and mentally able to complete the questionnaires
- locally-confined prostate cancer
- Planned robotic-assisted, laparoscopic, or open surgery radical prostatectomy
- Distance of residence to study center =60 km.

Exclusion Criteria

Because this is an observation of routine clinical practice, no patients meeting the inclusion criteria will be excluded.
- Lack of capacity for insight and consent (e.g., caregiver relationship, written/language barriers).
- Lack of manual or technical requirements for smartphone use e.g. lack of availability of Android-based smartphone.
- Patient lives >60km away from the study center (realization of follow-up appointment more difficult).
- Withdrawal of study consent by patient.
- ASA (American Society of Anesthesiology) classification > 3.

Study & Design

• Study Type: interventional
• Study Design: Not specified